Efudix Cream
1. WHAT EFUDIX CREAM IS AND WHAT IT IS USED FOR
2. BEFORE YOU USE EFUDIX CREAM
3. HOW TO USE EFUDIX CREAM
PACKAGE LEAFLET: INFORMATION FOR THE USER Efudix® Cream (fluorouracil)
Read all of this leaflet carefully before you start using
this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effect and this becomes serious, tell your doctor or pharmacist.
In this leaflet:
1. What Efudix Cream is and what it is used for
2. Before you use Efudix Cream
3. How to use Efudix Cream
4. Possible side effects
5. How to store Efudix Cream
6. Further information
Efudix Cream is used to treat skin conditions such as growths of the skin (keratoses) and some simple skin cancers. The active ingredient fluorouracil, belongs to a group of anti-cancer medicines.
Important Information About How Efudix Works
Efudix destroys cancerous and pre-cancerous cells, while having little effect on normal cells.
When you use Efudix it is likely that the area of the skin that you are treating will become red. This will probably be followed by inflammation/swelling, possibly some discomfort, skin erosion and eventually, healing. This is the expected normal response to treatment and shows that Efudix is working.
Sometimes the response is more severe (see section 4 “Possible Side Effects”). If your skin becomes much worse, you experience pain or if you are worried, talk to your doctor. Your doctor may prescribe you another cream to relieve any discomfort.
After stopping treatment you may find that your skin takes one to two months to heal completely.
Efudix will also treat abnormalities of the skin that were previously not visible to the naked eye, and these abnormalities may become red and inflamed.
Do not use Efudix Cream if you:
• are allergic (hypersensitive) to fluorouracil or any other ingredients in this medicine (these are listed in section 6, “Further Information”).
• are pregnant, think you may be pregnant, or are breastfeeding.
• are using any medicines known as antiviral nucleosides (e.g. brivudine, sorivudine). These medicines are usually used to treat chickenpox or shingles.
Take special care with Efudix Cream if you:
• are applying this cream around your eyelids, nose or lips, and avoid contact with the eyes or mouth (see section 3, “How to use Efudix Cream”).
• have open cuts. Do not use this cream on open cuts as this can lead to too much cream being absorbed into the blood, which very rarely, can cause side effects.
• have reduced activity/deficiency of the enzyme DPD (dihydropyrimidine dehydrogenase).
Sunlight may increase the effects of Efudix. This may result in increased skin reactions. To prevent this you must try to stay out of direct sunlight as much as possible while using the cream and must not use a sunlamp or sun bed.
Exposure to UV-radiation (e.g.) natural sunlight, tanning salon) should be avoided.
Closing bandages or dressing may increase inflammatory reactions of the skin.
Using other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is very important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines involved.
In particular, tell your doctor if you are using:
• medicines to treat chickenpox or shingles (brivudine, sorivudine) or have used them in the last 4 weeks. These medicines may increase the possibility of unwanted effects with Efudix Cream.
Pregnancy and breast-feeding
Do not use Efudix Cream and tell your doctor if you are pregnant, think you might be pregnant or you are breast-feeding.
Driving and using machines
It is unlikely that the treatment will have any effect on your ability to drive or use machines.
Important information about some of the ingredients of
Efudix Cream
Efudix Cream contains some ingredients that can cause side
effects. These are:
• stearyl alcohol and propylene glycol, which can cause local skin irritations (e.g. contact dermatitis, which is an inflammation of the skin).
• E218 (methyl parahydroxybenzoate) and E216 (propyl parahydroxybenzoate), which can cause allergic reactions.
Do not use Efudix if you are allergic to any of its ingredients.
Always use Efudix Cream exactly as your doctor has told you. You must check with your doctor or pharmacist if you are not sure. If you think that the effect of your medicine is too weak or strong, talk to your doctor. Do not change your dose without asking your doctor.
If you swallow some cream contact your doctor, pharmacist or go to your nearest hospital straight away.
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Efudix Cream is not for use in anyone under 18 years of age.
If any of the following occur, wash the cream off using water, then contact your doctor, pharmacist or go to your nearest hospital straight away:
• You get this cream in your eyes, nose or mouth.
• Someone else accidentally uses this cream.